Regulatory Specialist II (Oncology)

We are seeking a Regulatory Specialist II who will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. This role will serve as a central resource for faculty conducting clinical research. Specific Duties & Responsibilities * Collaborate with the Research Nurse and/or Principal Investigator to ensure timely and accurate submissions to the IRB and study sponsors. * Obtain and prepare all required documents for new IRB submissions, including initial study submissions. * Oversee the smooth implementation of new clinical trials from study conception through activation. * Coordinate with the protocol compliance team to ensure readiness of regulatory documents prior to study initiation. * Collect all required regulatory documents from participating sites when JHU/JHM serves as the coordinating center, ensuring timely collection * Develop and maintain standard operating procedures (SOPs). * Support auditing and monitoring activities, including those involving external sites. * Act as a central resource for faculty conducting clinical research. * Prepare and manage required regulatory documentation, including financial disclosure forms, delegation logs, FDA Form 1572, and others. * Maintain an organized regulatory binder (electronic or physical), initiating with required documents and structured for ongoing updates. * Ensure prompt reporting of serious adverse events (SAEs) and protocol deviations in accordance with applicable regulations. * Track protocol submissions through the IRB and relevant subcommittees, identifying bottlenecks and implementing process improvements. * Attend and contribute to study start-up meetings. * Participate in routine and as-needed monitoring visits. * Assist in preparation for and follow-up of regulatory inspections and audits. * Other duties as assigned. Minimum Qualifications * Bachelor's Degree. * Two years of experience in academic, government, or industry-based * Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula. * * * Classified Title: Regulatory Specialist II Role/Level/Range: ACRP/03/MB Starting Salary Range: $41,300 - $72,300 Annually ($56,800 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: Mon - Fri / 8:30a - 5p FLSA Status: Exempt Location: Hybrid/School of Medicine Campus Department name: SOM Onc Hematologic Malignancies Personnel area: School of Medicine